Please note, this OEL/ADE monograph also applies to Folate sodium (CAS RN 6484-89-5), Folcysteine (CAS RN 8064-47-9), Folic acid potassium salt (CAS RN 36653-55-1), Folic acid dihydrate (CAS RN 75708-92-8), Calcium folate (CAS RN 78168-16-8), Levomefolate glucosamine (CAS RN 1181972-37-1), Folitixorin (CAS RN 3432-99-3), Folitixorin calcium (CAS RN 133978-75-3), Folitixorin sodium (CAS RN 133978-76-4), Arfolitixorin monosulfate (CAS RN 149930-93-8), and Arfolitixorin hemisulfate (CAS RN 1654736-73-8). Folate is the generic name for a number of compounds having a similar activity as folic acid (pteroylglutamic acid (PGA)), being involved in single carbon (C1-) transfer reactions. Folic acid (PGA) is a synthetic folate compound used in food supplements and in food fortification because of its stability; it becomes biologically active after reduction. Natural (dietary) folates are mostly reduced folates, derivatives of tetrahydrofolate (THF), such as 5-methyl-THF (5- MTHF), 5-formyl-THF and 5,10-methylene-THF, and exist mainly as pteroylpolyglutamates, with up to nine additional glutamate molecules attached to the pteridine ring.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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